QA Sme

24 hours ago

Gujarat, India Zydus Group Full time

Org Structure
- ZHL DAMAN PLANT QA
- Job posted on
- Sep 15, 2025
- Employee Type
- C-C7-Confirmed-HO Staff
- Experience range (Years)
- 2 years - 5 years

**Sr. No.**

**Job Responsibility**
- 01
- Instrument Calibration Planning considering due date, communicate with External Party, Calibrated the Instruments which are installed in Area.
- 02
- Responsible for conducting and planning of Area Validation considering due date, correspondence with External Party, perform the Test as Air Velocity, PAO Test, Particle Count, Air Flow and Temperature Mapping.
- 03
- Balance Calibration Planning considering Due Date, inform to External Party, Calibrate the Balance which is available in Area. Monthly Calibrate the IPQC Instrument as per due date and fill-up the Formats.
- 04
- After Calibration and Validation Activity, Reviewing and compilation Reports.
- 05
- Preparation and Verification of Qualification Protocol for new Equipment.
- 06
- Preparation of new SOP related Validation.
- 07
- Preparation of IQ, OQ & PQ protocol, execution of activity and preparation of its Report.
- 08
- HVAC Validation for newly installed System, perform the IQ, OQ & PQ and preparation of its Report.
- 09
- Vial Washing Machine, Depyrogenation Tunnel and Autoclave Qualification.
- 10
- Media Fill Protocol Preparation, Execution and Review of its BMR & Video Recording.
- 11
- Process Gas Qualification.
- 12
- Handling, Evaluation & Investigation of Deviation Control and Change Control.
- 13
- To give Area Line Clearance at various stages of manufacturing and Packing by verifying checkpoints as per respective area checklist in Injection Department.
- 14
- Verify the Process Validation up to its completion of three batches of new product and BMR finalization.
- 15
- To perform in process of various Stages of Manufacturing and Packing.
- 16
- To perform Sampling as per Sampling plan at various stages of Manufacturing and Packing.
- 17
- To perform Environmental Monitoring in Manufacturing Area.
- 18
- Coordinating in CAPA & Market Complaint activity.
- 19
- Responsible for Control Sample Management Activity.
- 20
- Responsible for Stability Management activity of QA in QC.
- 21
- 1. Review of departmental SOP’s for verification of adequacy of the defined procedure and ensure compliance.
- 22
- Responsible for quality oversight of personnel, process and practice to meet the cGMP and compliance requirement. To verify the system & identify the gaps for improvement.

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